On Thursday, HC Wainwright initiated coverage on Relmada Therapeutics Inc. (RLMD) with a Buy rating and a $12 price target, putting the spotlight on the company's lead candidate for bladder cancer. The clinical-stage biotech is developing therapies for oncology and central nervous system conditions, with NDV-01 and sepranolone as its main prospects.
Relmada released promising interim data from its Phase 2 trial of NDV-01 for treating non-muscle invasive bladder cancer (NMIBC) back in March. The 12-month results showed a complete response rate of 76%, and that number jumped to 80% in patients who didn't respond to BCG therapy, a standard treatment that's been in short supply. Even more striking, the trial reported a 95% complete response rate at any time in high-risk patients, and 94% in the BCG-unresponsive group.
In April 2026, Relmada filed a provisional patent application with the USPTO covering NDV-01 formulations and treatment methods. If granted, any resulting patents could protect the drug through April 2047, giving the company a long runway to commercialize the therapy.
HC Wainwright analyst Andres Maldonado described NDV-01 as "a next-generation delivery platform for a familiar and increasingly validated intravesical chemotherapy backbone rather than a wholly novel therapeutic modality." In plain English, it's not a brand-new drug mechanism, but a smarter way to deliver an existing chemotherapy cocktail (Gem/Doce) directly into the bladder. That distinction matters because Gem/Doce has already gained traction in NMIBC, especially as BCG shortages have pushed doctors to look for alternatives. But the current way of administering it is a hassle: sequential installations, long chair time, pharmacy coordination, and multi-hour clinic visits. NDV-01 aims to simplify that.
Maldonado noted that "the field is moving toward a multi-agent bladder-sparing ecosystem, where therapies like NDV-01 can be differentiated by durable recurrence control, clean safety, simple administration, lower treatment burden, and broad community-urology compatibility." In other words, if NDV-01 can deliver the same efficacy with less hassle, it could carve out a nice niche.
Investors have already taken notice. RLMD shares are up 800% over the past year, compared to a 12% gain for the biotech index XBI. That's a massive re-rating, though the stock dipped 0.98% to $6.53 on Thursday, according to market data.
With a $12 price target from HC Wainwright, there's still room to run if NDV-01 continues to deliver in the clinic. But as always with biotech, the road from here to approval is paved with data, regulatory hurdles, and a fair bit of luck.
